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FDA 510(k)

SEAL RING FOR NASAL CPAP

K-Number: K921499 · 1992-09-17

ApplicantDevilbiss Health Care, Inc.
Decision Date1992-09-17
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SEAL RING FOR NASAL CPAP is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Health Care, Inc.. It received FDA 510(k) clearance on 1992-09-17 under 510(k) number K921499. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEAL RING FOR NASAL CPAP?

SEAL RING FOR NASAL CPAP is a medical device that received FDA 510(k) clearance on 1992-09-17. The listed applicant is Devilbiss Health Care, Inc.. The 510(k) number is K921499.

When did SEAL RING FOR NASAL CPAP receive FDA 510(k) clearance?

SEAL RING FOR NASAL CPAP received FDA 510(k) clearance on 1992-09-17, under 510(k) number K921499.

Who is the listed applicant for SEAL RING FOR NASAL CPAP?

The FDA 510(k) record lists Devilbiss Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEAL RING FOR NASAL CPAP?

The FDA product code for SEAL RING FOR NASAL CPAP is BYG.

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Other records listing Devilbiss Health Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963349DEVILBISS 8650DK970289COMPRESSOR/NEBULIZER #3650K961126PULSE DOSE SERIESK950849MODEL #7354K952491MODEL 7355K952249JET NEBULIZER

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Related Devices (Code: BYG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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